FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR


Device Classification Name

accessory, assisted reproduction

510(k) Number K991408
Device Name FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
Applicant
THERMOQUEST CORP.
mill creek rd.
marietta, 
OH 
45750

Applicant Contact richard l miller
Correspondent
THERMOQUEST CORP.
mill creek rd.
marietta, 
OH 
45750

Correspodent Contact richard l miller
Regulation Number 884.6120
Classification Product Code
MQG  
Date Received 04/22/1999
Decision Date 07/19/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No